Botanical Review Team Develops “Post-CMC” Approach
This article was originally published in Pharmaceutical Approvals Monthly
FDA’s Botanical Review Team has identified new ways to help assure the quality of complex natural mixtures. While not specified in the agency’s 2004 guidance on botanical drugs, the team is adding its “post-CMC” approach to conventional CMC analyses and “pre-CMC” agricultural oversight.
You may also be interested in...
Review documents show that Fulyzaq’s clear, if modest, treatment effect compared to placebo was buttressed by a series of exploratory subgroup analyses suggesting greater efficacy in sicker patients.
Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.
Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.